Gulf Coast Regional Blood Center FDA Record
- Latest inspection NAI · Mar 31, 2026
- No warning letters matched by name
Gulf Coast Regional Blood Center has 0 FDA recalls, 53 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gulf Coast Regional Blood Center" is on file.
- Latest inspection
- Mar 31, 2026 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 53 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Gulf Coast Regional Blood Center: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 2 | 0 | 0 | 0 | 0 |
| 2024 | 4 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 4 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 3 | 0 | 0 | 0 | 0 |
| 2018 | 3 | 0 | 0 | 0 | 0 |
| 2017 | 6 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 31, 2026 | Houston, TX | Biologics | No Action Indicated (NAI) | 3003949974 |
| Jun 27, 2025 | College Station, TX | Biologics | No Action Indicated (NAI) | 3006521863 |
| Feb 28, 2025 | Houston, TX | Biologics | No Action Indicated (NAI) | 3002133806 |
| Dec 9, 2024 | Nacogdoches, TX | Biologics | No Action Indicated (NAI) | 1627657 |
| Oct 30, 2024 | Lufkin, TX | Biologics | No Action Indicated (NAI) | 3005096242 |
| Jul 17, 2024 | The Woodlands, TX | Biologics | No Action Indicated (NAI) | 3005056388 |
| Jul 12, 2024 | Cypress, TX | Biologics | No Action Indicated (NAI) | 3013944506 |
| Nov 10, 2022 | Katy, TX | Biologics | No Action Indicated (NAI) | 3004723016 |
| Sep 14, 2022 | Houston, TX | Biologics | No Action Indicated (NAI) | 3002133806 |
| Sep 2, 2022 | Sugar Land, TX | Biologics | No Action Indicated (NAI) | 3003949984 |
| Mar 24, 2022 | College Station, TX | Biologics | No Action Indicated (NAI) | 3006521863 |
| Jan 31, 2020 | Houston, TX | Biologics | No Action Indicated (NAI) | 3003949974 |
| Dec 11, 2019 | The Woodlands, TX | Biologics | No Action Indicated (NAI) | 3005056388 |
| Jun 11, 2019 | Lufkin, TX | Biologics | No Action Indicated (NAI) | 3005096242 |
| Jun 7, 2019 | Nacogdoches, TX | Biologics | No Action Indicated (NAI) | 1627657 |
| Oct 16, 2018 | Cypress, TX | Biologics | No Action Indicated (NAI) | 3013944506 |
| Aug 8, 2018 | Katy, TX | Biologics | No Action Indicated (NAI) | 3004723016 |
| May 25, 2018 | Houston, TX | Biologics | No Action Indicated (NAI) | 3003949974 |
| Dec 14, 2017 | The Woodlands, TX | Biologics | No Action Indicated (NAI) | 3005056388 |
| Nov 7, 2017 | Sugar Land, TX | Biologics | No Action Indicated (NAI) | 3003949984 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003949974 | Houston, TX | 7 | Mar 31, 2026 |
| FEI 3006521863 | College Station, TX | 6 | Jun 27, 2025 |
| FEI 3002133806 | Houston, TX | 6 | Feb 28, 2025 |
| FEI 1627657 | Nacogdoches, TX | 7 | Dec 9, 2024 |
| FEI 3005096242 | Lufkin, TX | 7 | Oct 30, 2024 |
| FEI 3005056388 | The Woodlands, TX | 7 | Jul 17, 2024 |
| FEI 3013944506 | Cypress, TX | 2 | Jul 12, 2024 |
| FEI 3004723016 | Katy, TX | 5 | Nov 10, 2022 |
| FEI 3003949984 | Sugar Land, TX | 6 | Sep 2, 2022 |
Gulf Coast Regional Blood Center and the FDA: common questions
Has Gulf Coast Regional Blood Center received an FDA warning letter?
No FDA warning letter addressed to the name "Gulf Coast Regional Blood Center" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Gulf Coast Regional Blood Center received an FDA Form 483?
FDA has not published a Form 483 for "Gulf Coast Regional Blood Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Gulf Coast Regional Blood Center?
The most recent FDA inspection on file ended Mar 31, 2026 at Houston, TX and was classified NAI. FDA has 53 inspections of Gulf Coast Regional Blood Center on file.
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